Trial Outcomes & Findings for Human Comedogenicity Test (NCT NCT03428997)

Last Updated: 2023-07-03

Results Overview

Grades for irritations/reactions were The following 5-point global assessment scale was used to grade the follicular biopsies for microcomedones: 0 None (0% No microcomedones) 0.5 Slight (1-24% Smallish horny masses) 1. Mild (25-49% Smallish horny masses) 2. Moderate (50-74% Moderately sized horny masses) 3. Severe (75-100% Larger globoid microcomedones)

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

28 days

Results posted on

2023-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	Lotion and Negative Control The Formulation Lotion F#13541-131 on an occlusive patch and the undosed occlusive patch (negative control) were each applied to a test site on each subject's back three times a week for four weeks.
Overall Study STARTED	24
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Lotion and Negative Control The Formulation Lotion F#13541-131 on an occlusive patch and the undosed occlusive patch (negative control) were each applied to a test site on each subject's back three times a week for four weeks.
Overall Study Sponsor decision.	1
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	4

Baseline Characteristics

Human Comedogenicity Test

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lotion and Negative Control n=16 Participants The Formulation Lotion F#13541-131 on an occlusive patch and the undosed occlusive patch (negative control) were each applied to a test site on each subject's back three times a week for four weeks.
Age, Continuous	36.8 Years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: All study participants received both the test product and a negative control following a randomization.

Outcome measures

Outcome measures
Measure	Lotion n=16 Test Site The Formulation Lotion F#13541-131 on an occlusive patch was applied to a test site on each subject's back three times a week for four weeks.	Negative Control n=16 Test Site Undosed occlusive patch (negative control) was applied to a test site on each subject's back three times a week for four weeks.
Microcomedone Score of Follicular Biopsies	0.84 microcomedone score Standard Deviation 0.51	0.97 microcomedone score Standard Deviation 0.56

Adverse Events

Lotion

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Negative Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lotion n=24 participants at risk The Formulation Lotion F#13541-131 on an occlusive patch was applied to a test site on each subject's back three times a week for four weeks.	Negative Control n=24 participants at risk The undosed occlusive patch (negative control) was applied to a test site on each subjects back three times a week for four weeks.
Skin and subcutaneous tissue disorders Erythema	16.7% 4/24 • Number of events 4 • 8 weeks All of the Adverse Events recorded during the study were related to test material sites.	0.00% 0/24 • 8 weeks All of the Adverse Events recorded during the study were related to test material sites.
Skin and subcutaneous tissue disorders Cracking/Fissures/Dryness/Scabbing	12.5% 3/24 • Number of events 3 • 8 weeks All of the Adverse Events recorded during the study were related to test material sites.	0.00% 0/24 • 8 weeks All of the Adverse Events recorded during the study were related to test material sites.
Skin and subcutaneous tissue disorders Edema	8.3% 2/24 • Number of events 2 • 8 weeks All of the Adverse Events recorded during the study were related to test material sites.	0.00% 0/24 • 8 weeks All of the Adverse Events recorded during the study were related to test material sites.
Skin and subcutaneous tissue disorders Papule	4.2% 1/24 • Number of events 1 • 8 weeks All of the Adverse Events recorded during the study were related to test material sites.	0.00% 0/24 • 8 weeks All of the Adverse Events recorded during the study were related to test material sites.
Skin and subcutaneous tissue disorders Pustule	4.2% 1/24 • Number of events 1 • 8 weeks All of the Adverse Events recorded during the study were related to test material sites.	0.00% 0/24 • 8 weeks All of the Adverse Events recorded during the study were related to test material sites.
Skin and subcutaneous tissue disorders Vessicles	4.2% 1/24 • Number of events 1 • 8 weeks All of the Adverse Events recorded during the study were related to test material sites.	0.00% 0/24 • 8 weeks All of the Adverse Events recorded during the study were related to test material sites.

Additional Information

Heather Smith

Johnson & Johnson Consumer Inc.

Phone: (908) 874-1235

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Principal Investigator (PI) will provide Sponsor with at least sixty (60) days to review any Publication. No Publication that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written consent. If requested in writing, the PI withholds such Publication for up to an additional sixty (60) days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER